UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014614
Receipt number R000015412
Scientific Title Objective evaluation of pain
Date of disclosure of the study information 2014/08/01
Last modified on 2021/01/15 10:47:05

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Basic information

Public title

Objective evaluation of pain

Acronym

Objective evaluation of pain

Scientific Title

Objective evaluation of pain

Scientific Title:Acronym

Objective evaluation of pain

Region

Japan


Condition

Condition

healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We are going to seek the objective way for evaluating pain

Basic objectives2

Others

Basic objectives -Others

We are going to measure various vital signs including ECG and skin conductance during painful and non-painful stimulus for seeking the objective way for evaluating pain.

Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

1. We are going to investigate the relationship between numerical rating scale and vital signs including skin conductance, heart rate variability, and arterial oxygen saturation during heat stimulation.
2. We are going to compare the changes in skin conductance after 5 different stimuli.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment Other

Interventions/Control_1

The device for heat and mechanical stimulation, skin conductance monitor,audiometer

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

60 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy adults between 20 and 60 years old with informed consent

Key exclusion criteria

Subject with chronic pain
Subject who can not understand the protocol
Subject who can not tolerate heat stimulus
Subject who has a medication acting on autonomic nerve system
Subject who is not suitable for giving heat stimulus due to severe disease
Pregnant woman

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Satomi
Middle name
Last name Sugimine

Organization

Gunma University Hospital

Division name

Department of Anesthesiology

Zip code

371-8511

Address

3-39-15 Showa-machi, Maebashi, Gunma 371-8511, Japan

TEL

027-220-8454

Email

s-satomi@umin.ac.jp


Public contact

Name of contact person

1st name Satomi
Middle name
Last name Sugimine

Organization

Gunma University Hospital

Division name

Department of Anesthesiology

Zip code

3718511

Address

3-39-15 Showa-machi, Maebashi, Gunma 371-8511, Japan

TEL

027-220-8454

Homepage URL


Email

s-satomi@umin.ac.jp


Sponsor or person

Institute

Department of Anesthesiology, Gunma University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Gunma University Hospital

Address

3-39-15, showa-machi, maebashi-shi, Gunma-ken

Tel

027-220-7111

Email

gunmaciru-office@umin.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

群馬大学医学部附属病院(群馬県)


Other administrative information

Date of disclosure of the study information

2014 Year 08 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 04 Month 24 Day

Date of IRB

2013 Year 04 Month 24 Day

Anticipated trial start date

2014 Year 07 Month 22 Day

Last follow-up date

2015 Year 10 Month 15 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 07 Month 22 Day

Last modified on

2021 Year 01 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015412


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name